Sorin LivaNova 3T Heater-Cooler

The US Judicial Panel on Multidistrict Litigation (JPMDL) will hear argument on March 30 on whether to create new multi-district litigation docket (MDL) No. 2776 for Farxiga and Xigudo diabetes medicines.

Oral argument is scheduled starting in the morning at the US Courthouse in Phoenix, Arizona. In addition, oral arguments will be held to create the following MDLs:

Ketoacidosis and kidney failure

Plaintiff’s attorney Holly Dolejsi of Robins Kaplan L.L.P. in Minneapolis moved to transfer currently filed Faxiga and Xigduo cases to either the Southern District of New York before Judge Lorna G. Schofield, the Eastern District of Pennsylvania before Judge Mitchell Goldberg, or the Southern District of Illinois before Judge Nancy J. Rosenstengel, who all have Farxiga cases assigned to them.

The motion involves 18 pending cases in 6 district courts, with 13 of the 18 filed in New York. The Defendants The Defendants in these cases are Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca AB, and AstraZeneca PLC.

As a result of ingesting Farxiga, the plaintiffs have suffered sudden onset of life-threatening diabetic ketoacidosis (often in the setting of normal blood glucose levels), and/or acute renal failure, and/or pyelonephritis (kidney infection) and/or urosepsis and continue to suffer from the sequelae of these injuries. Farxiga (dapagliflozin) is a pharmaceutical drug used to treat Type 2 Diabetes. All of these injuries were the subject of recent FDA safety advisories. On January 8, 2014, the FDA approved Farxiga for use in

On January 8, 2014, the FDA approved Farxiga for use in treatment of type 2 diabetics.2 Farxiga is a part of the gliflozin drug class. The gliflozin class is referred to generally as SGLT2 (short for “Sodium Glucose Cotransporter 2”) inhibitors. Xigduo XR was (dapagliflozin combined with metformin) designed and made by the same defendants as Farxiga, and is an extension of the Farxiga product line. Xigduo XR was approved shortly after Farxiga, on October 29, 2014.

FDA safety warning

On December 4, 2015 the FDA issued a safety communication disclosing they had found 73 adverse events reported between March 2013 and May 2015 that required hospitalization due to ketoacidosis-related to SGLT2 inhibitors. The FDA noted adverse event reports “include only reports submitted to FDA, so there are likely additional cases about which we are unaware.”

The same safety communication also warned of “life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis). In light of the data disclosed in the December 4, 2015 safety communication, the FDA changed the label for Farxiga and Xigduo XR to include a warning “about the risks of too much acid in the blood” and urged patients taking SGLT2 inhibitors to stop taking the drug and seek immediate medical attention if they have any symptoms of ketoacidosis. The FDA also required a label change to warn of urosepsis and pyelonephritis. On June 14, 2016, the FDA issued a safety announcement which advised that the existing warning about the risk of acute kidney injury on the Farxiga and Xigduo labels would be strengthened.

While a cross-motion to include Farxiga cases with Invokana MDL No. 2750 was raised, considered and ultimately denied by the Panel following the hearing in Charlotte, North Carolina, that request was opposed by both the Invokana Plaintiffs’ counsel and Defendants who claimed that the litigations were sufficiently different such that a joint SGLT2 MDL was improvident.

A total of 100 lawsuits have been filed in the MDL since the courts created it in December.

Sorin Group Stöckert 3T Heater-Cooler System manufactured by LivaNova PLC

Following damning reports from the FDA and the Centers for Disease Control and Prevention, the first lawsuit against the Sorin Stöckert 3T Heater-Cooler medical device for open-heart surgery has been filed in US District Court in South Carolina.

The defective medical devices, made by LivaNova in Munich, Germany, were contaminated with Mycobacterium chimaera. Two months after Fowler had the cardiac bypass procedure on April 2, 2014, doctors discovered the infection at the surgical wound site. He had to undergo many more surgeries and antibiotic therapy.

Damning evidence

More than 250,000 heart bypass procedures using heater-cooler devices are performed in the US every year. Approximately 60 percent of heart bypass procedures performed in the U.S. use the Sorin Group Stöckert 3T heater-cooler devices.

The devices regulate a patient’s body temperature. Scientists believe that some of the systems have contaminated water that evaporates into the air, exits the machine through a vent, and enters the patient’s lungs or open chest cavity. The infection can take days, weeks, or months to develop and must be treated with a one-to-two year round of antibiotics.

Evidence is mounting against the device:

The CDC warned healthcare providers and patients on October 13, 2016 about the potential risk of infection from the Stöckert 3T.

The Greenville Health System Hospital on July 21, 2014 outlined safety measures for a “cardioplegia machine” connected to a rare non-tuberculosis mycobacterium infection that infected 14 patients during open heart surgeries. GHS indicated that there had been four deaths resulting from the same infection.

On July 15, 2015, the FDA issued a Class II Recall of the Sorin 3T System due to the “potential colonization of organisms, including Mycobacteria” in Sorin Heater Cooler Devices.

On December 29, 2015, the FDA issued a Warning Letter to the defendants, which indicated that its inspection of Sorin’s Germany and Colorado facilities revealed that the Sorin 3T System devices had been “adulterated.”

Not surprisingly, the device was approved in a short-cut 510(k) application by the FDA on June 6, 2006, which means it did not go through clinical trials because it was “equivalent” to a predicate device.

“Despite Defendants’ knowledge of the catastrophic injuries, conditions, and complications caused by the Sorin 3T System, in violation of Federal and State requirements, it continued to manufacture, market, provide inadequate instructions for use, and sell the Sorin 3T System, and also failed to adequately warn, label, instruct, and disseminate information with regard to Defendants’ Sorin 3T System both prior toand after the marketing and sale of the System,” the complaint states.